Clinical investigation of anti-psoriatic efficacy and atrophy
In this trial three concentrations of bexarotene in combination with a fixed concentration of betamethasone dipropionate, as well as monotherapy with bexarotene, will be investigated regarding their efficacy, tolerability and safety in patients with mild to moderate plaque psoriasis and will be compared with the vehicle and an active comparator. Since a side effect of the application of corticosteroids is skin atrophy, additionally three non-lesional test areas (not affected by psoriasis) on the volar forearm will be treated with the active reference product, one of the fixed combinations and the vehicle. Skin atrophy will be investigated by visual assessment and ultrasound at these test areas
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
daily topical application
daily topical application
daily topical application
proDERM GmbH
Schenefeld, Schleswig-Holstein, Germany
Area under the curve, AUC, of the width of the echo-lucent band based on sonography measurements
The primary objective is to gain evidence suggesting efficacy of the investigational products in the treatment of plaque-type psoriasis as assessed by the AUC of the width of the echo-lucent band
Time frame: day 1 vs day 29
erythema and induration
investigation of the individual scores for erythema and induration
Time frame: day 1 vs day 29
local skin tolerability
Safety investigation of tolerability parameters assessed by a dermatologist
Time frame: every day for 28 days
atrophy
investigation of skin atrophy assessments on non-lesional test areas
Time frame: day1 vs day 29
assessment of (serious) Adverse Events
Daily record will be performed and - if needed - causality and severity assessed
Time frame: from baseline to day 29
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daily topical application
daily topical application
once daily, topical